bupropion Hydrochloride NDC 71335-0877

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0877Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0877Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
71335-0877-1	71335087701	60 TABLET in 1 BOTTLE (71335-0877-1)Marketed from Sep 7, 2018
71335-0877-2	71335087702	30 TABLET in 1 BOTTLE (71335-0877-2)Marketed from Jun 21, 2018
71335-0877-3	71335087703	100 TABLET in 1 BOTTLE (71335-0877-3)Marketed from Dec 27, 2021
71335-0877-4	71335087704	90 TABLET in 1 BOTTLE (71335-0877-4)Marketed from Sep 13, 2018
71335-0877-5	71335087705	120 TABLET in 1 BOTTLE (71335-0877-5)Marketed from Dec 27, 2021
71335-0877-6	71335087706	15 TABLET in 1 BOTTLE (71335-0877-6)Marketed from Dec 27, 2021
71335-0877-7	71335087707	21 TABLET in 1 BOTTLE (71335-0877-7)Marketed from Dec 27, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): bupropion Hydrochloride
Generic name (nonproprietary): bupropion hydrochloride
Active ingredients: Bupropion hydrochloride — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207389
Marketing start: May 26, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71335-0877_7a02762a-5d8d-4874-9fc2-b4d74458eee7SPL ID 7a02762a-5d8d-4874-9fc2-b4d74458eee7SPL set ID c1fa6fce-272b-4497-a958-177f0bafdfc7RxCUI 993687UNII ZG7E5POY8O
Pharmacologic class: Aminoketone

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471335087701 followed by a unit qualifier and the quantity

Package 71335-0877-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14) ]. Bupropion hydrochloride is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207389

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207389
Product	Strength	Form · route	Labeler	Product NDC
bupropion Hydrochloride	Bupropion hydrochloride 75 mg/1	TabletOral	CIPLA USA INC.,	69097-917
bupropion Hydrochloride	Bupropion hydrochloride 100 mg/1	TabletOral	CIPLA USA INC.,	69097-918